Duns Number:368457563
Device Description: Leg Attachment Pad for Corometrics; Fetal Scalp Electrode Cable
Catalog Number
2464AAO
Brand Name
N/A
Version/Model Number
2464AAO
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
e52b4111-c599-4742-9018-c6782360b046
Public Version Date
December 16, 2020
Public Version Number
1
DI Record Publish Date
December 08, 2020
Package DI Number
20190752145334
Quantity per Package
50
Contains DI Package
10190752145337
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 600 |